System and method of displaying stimulation map and pain map overlap coverage representation

ABSTRACT

A method of displaying pain or stimulation experienced by a patient includes providing a graphical user interface configured to receive an input from a user and display a visual output to the user. A first map and a second map are concurrently displayed via the graphical user interface. The first map and the second map are each a pain map or a stimulation map. The pain map represents a body area of the patient experiencing pain. The stimulation map represents a body area of the patient experiencing electrical stimulation. A virtual control mechanism is displayed via the graphical user interface. Through the graphical user interface, an engagement of the virtual control mechanism is detected. In response to the engagement of the virtual control mechanism, respective visual emphases of the first map and the second map are simultaneously adjusted.

PRIORITY DATA

The present application is a utility application of provisional U.S.Patent Application No. 61/824,296, filed on May 16, 2013, entitled“Features and Functionalities of an Advanced Clinician Programmer,” thedisclosures of which is hereby incorporated by reference in itsentirety.

BACKGROUND

As medical device technologies continue to evolve, active implantedmedical devices have gained increasing popularity in the medical field.For example, one type of implanted medical device includesneurostimulator devices, which are battery-powered or battery-lessdevices that are designed to deliver electrical stimulation to apatient. Through proper electrical stimulation, the neurostimulatordevices can provide pain relief for patients or restore bodilyfunctions.

Implanted medical devices (for example a neurostimulator) can becontrolled using an electronic programming device such as a clinicianprogrammer or a patient programmer. These programmers can be used bymedical personnel or the patient to define the particular electricalstimulation therapy to be delivered to a target area of the patient'sbody, alter one or more parameters of the electrical stimulationtherapy, or otherwise conduct communications with a patient. Advances inthe medical device field have improved these electronic programmers. Forexample, some existing programmers allow the creation and display ofpain maps and stimulation maps as part of the pain diagnosis andcommunication with the patient. However, the pain maps and stimulationmaps on existing programmers have certain shortcomings. For example,conventional systems and methods of displaying pain maps and/orstimulation maps typically display the pain maps and/or stimulation mapsat a single snapshot in time. As another example, conventional systemsand method may not offer the user a clear and intuitive representationof how a pain map is overlapped with a stimulation map or with anotherpain map. Therefore, conventional methods of displaying pain maps andstimulation maps may not give the healthcare professional sufficientinformation to effectively treat the patient.

Therefore, although existing systems and methods for generating anddisplaying pain maps and stimulation maps have been generally adequatefor their intended purposes, they have not been entirely satisfactory inevery aspect.

SUMMARY

One aspect of the present disclosure involves an electronic device forvisualizing a sensation experienced by a patient. The electronic deviceincludes: a graphical user interface configured to receive an input froma user and display a visual output to the user; a memory storagecomponent configured to store programming code; and a computer processorconfigured to execute the programming code to perform the followingtasks: displaying a virtual control mechanism on the graphical userinterface; detecting, through the graphical user interface, one or moreengagements of the virtual control mechanism; and displaying, inresponse to the engagement of the virtual control mechanism, a sensationmap history on the graphical user interface, wherein the sensation maphistory graphically depicts a migration of a sensation map over time ona virtual human body model.

Another aspect of the present disclosure involves a medical system. Themedical system includes: one or more medical devices configurable todeliver a medical therapy to a patient; and an electronic deviceconfigured to program the one or more medical devices. The electronicdevice includes: a graphical user interface configured to receive aninput from a user and display a visual output to the user; a memorystorage component configured to store computer instructions; and aprocessor component configured to execute the computer instructions toperform the following tasks: displaying a virtual control mechanism onthe graphical user interface; detecting, through the graphical userinterface, one or more engagements of the virtual control mechanism; anddisplaying, in response to the engagement of the virtual controlmechanism, a sensation map history on the graphical user interface,wherein the sensation map history graphically depicts a migration of asensation map over time on a virtual human body model.

Yet another aspect of the present disclosure involves method ofvisualizing a sensation experienced by a patient. The method includes:providing a graphical user interface configured to receive an input froma user and display a visual output to the user; displaying a virtualcontrol mechanism on the graphical user interface; detecting, throughthe graphical user interface, one or more engagements of the virtualcontrol mechanism; and displaying, in response to the engagement of thevirtual control mechanism, a sensation map history on the graphical userinterface, wherein the sensation map history graphically depicts amigration of a sensation map over time on a virtual human body model.

One more aspect of the present disclosure involves an electronicapparatus. The electronic apparatus includes: means for receiving aninput from a user and displaying a visual output to the user; means fordisplaying a slider bar and a marker movable along the slide bar,wherein a length of the slider bar corresponds to a predefined period oftime; means for detecting a movement of the marker along the slider bar;and means for displaying, in response to the detected movement of themarker along the slider bar, a sensation map history that graphicallydepicts, on a virtual human body model, a migration of pain orstimulation experienced by the patient over the predefined period oftime, and wherein the means for displaying the sensation map historycomprises means for automatically updating the displayed sensation maphistory in real time as the marker is moved along the slider bar.

Yet another aspect of the present disclosure involves an electronicdevice. The electronic device includes: a graphical user interfaceconfigured to receive an input from a user and display a visual outputto the user; a memory storage component configured to store programmingcode; and a computer processor configured to execute the programmingcode to perform the following tasks: concurrently displaying a first mapand a second map via the graphical user interface, wherein the first mapand the second map are each a pain map or a stimulation map, wherein thepain map represents a body area of the patient experiencing pain, andwherein the stimulation map represents a body area of the patientexperiencing electrical stimulation; displaying a virtual controlmechanism via the graphical user interface; detecting, through thegraphical user interface, an engagement of the virtual controlmechanism; and adjusting, in response to the engagement of the virtualcontrol mechanism, a respective visual emphasis of the first map and thesecond map, further comprising: increasing a visual emphasis of at leasta portion of the first map while decreasing a visual emphasis of atleast a portion of the second map; or decreasing the visual emphasis ofat least a portion of the first map while increasing the visual emphasisof at least a portion of the second map.

Another aspect of the present disclosure involves a medical system. Themedical system includes one or more medical devices configurable todeliver a medical therapy to a patient and an electronic deviceconfigured to program the one or more medical devices. The electronicdevice includes: a graphical user interface configured to receive aninput from a user and display a visual output to the user; a memorystorage component configured to store computer instructions; and aprocessor component configured to execute the computer instructions toperform the following tasks: concurrently displaying a first map and asecond map via the graphical user interface, wherein the first map andthe second map are each a pain map or a stimulation map, wherein thepain map represents a body area of the patient experiencing pain, andwherein the stimulation map represents a body area of the patientexperiencing electrical stimulation; displaying a virtual controlmechanism via the graphical user interface; detecting, through thegraphical user interface, an engagement of the virtual controlmechanism; and adjusting, in response to the engagement of the virtualcontrol mechanism, a respective visual emphasis of the first map and thesecond map, further comprising: increasing a visual emphasis of at leasta portion of the first map while decreasing a visual emphasis of atleast a portion of the second map; or decreasing the visual emphasis ofat least a portion of the first map while increasing the visual emphasisof at least a portion of the second map.

One more aspect of the present disclosure involves a method ofdisplaying pain or stimulation experienced by a patient. The methodincludes: providing a graphical user interface configured to receive aninput from a user and display a visual output to the user; concurrentlydisplaying a first map and a second map via the graphical userinterface, wherein the first map and the second map are each a pain mapor a stimulation map, wherein the pain map represents a body area of thepatient experiencing pain, and wherein the stimulation map represents abody area of the patient experiencing electrical stimulation; displayinga virtual control mechanism via the graphical user interface; detecting,through the graphical user interface, an engagement of the virtualcontrol mechanism; and adjusting, in response to the engagement of thevirtual control mechanism, a respective visual emphasis of the first mapand the second map, further comprising: increasing a visual emphasis ofat least a portion of the first map while decreasing a visual emphasisof at least a portion of the second map; or decreasing the visualemphasis of at least a portion of the first map while increasing thevisual emphasis of at least a portion of the second map; wherein theproviding of the graphical user interface, the concurrently displayingthe pain map and the stimulation map, the displaying of the virtualcontrol mechanism, the detecting of the engagement of the virtualcontrol mechanism, and the adjusting of the respective visual emphasisare each performed by one or more electronic processors.

BRIEF DESCRIPTION OF THE DRAWINGS

Aspects of the present disclosure are best understood from the followingdetailed description when read with the accompanying figures. It isemphasized that, in accordance with the standard practice in theindustry, various features are not drawn to scale. In fact, thedimensions of the various features may be arbitrarily increased orreduced for clarity of discussion. In the figures, elements having thesame designation have the same or similar functions.

FIG. 1 is a simplified block diagram of an example medical environmentin which evaluations of a patient may be conducted according to variousembodiments of the present disclosure.

FIGS. 2, 3A-3B, 4A-4B, 5A-5B, and 6-25 are graphical user interfaces forgenerating and displaying pain/stimulation maps according to variousaspects of the embodiments disclosure.

FIGS. 26-27 are flowcharts illustrating different example methods ofgenerating and displaying pain/stimulation maps according to variousembodiments of the present disclosure.

FIG. 28 is a simplified block diagram of an electronic programmeraccording to various embodiments of the present disclosure.

FIG. 29 is a simplified block diagram of an implantable medical deviceaccording to various embodiments of the present disclosure.

FIG. 30 is a simplified block diagram of a medical system/infrastructureaccording to various embodiments of the present disclosure.

FIGS. 31A and 31B are side and posterior views of a human spine,respectively.

DETAILED DESCRIPTION

It is to be understood that the following disclosure provides manydifferent embodiments, or examples, for implementing different featuresof the invention. Specific examples of components and arrangements aredescribed below to simplify the present disclosure. These are, ofcourse, merely examples and are not intended to be limiting. Variousfeatures may be arbitrarily drawn to different scales for simplicity andclarity.

In recent years, the use of active implanted medical devices has becomeincreasingly prevalent. Some of these implanted medical devices includeneurostimulator devices that are capable of providing pain relief bydelivering electrical stimulation to a patient. In that regards,electronic programmers have been used to configure or program suchneurostimulators (or other types of suitable active implanted medicaldevices) so that they can be operated in a certain manner. Suchelectronic programmers include clinician programmers and patientprogrammers, each of which may be a handheld device. For example, aclinician programmer allows a medical professional (e.g., a doctor or anurse) to define the particular electrical stimulation therapy to bedelivered to a target area of the patient's body, while a patientprogrammer allows a patient to alter one or more parameters of theelectrical stimulation therapy.

Over the years, such electronic programmers have achieved significantimprovements, for example, improvements in size, power consumption,lifetime, and ease of use. For instance, electronic programmers havebeen used to generate and/or display pain maps and stimulation maps(which may be collectively referred to as sensation maps) for a patient.In general, a pain map shows the location or intensity of a patient'spain, and a stimulation map shows the location or intensity of theelectrical stimulation (e.g., stimulation delivered by theneurostimulator) perceived by the patient. Such pain/stimulation mapscan serve as useful tools for diagnosing the patient's pain andtreatment and also allow visual/non-verbal communication between apatient and a healthcare professional. In addition, a history of themaps, if collected, can provide a record of a patient's treatmentprogress, and the maps can also be analyzed across patient groups. Insome embodiments, to protect patient privacy, the personal informationof the patients is stripped before the history of the pain/stimulationmaps are collected and analyzed. In other words, the history of thepain/stimulation maps may be collected and analyzed anonymously incertain embodiments.

Nevertheless, the generation and display of pain/stimulation maps inexisting programmers in the medical field may still have drawbacks. Forexample, conventional systems and methods are not capable of providing amigration history of a pain map and/or a stimulation map over a periodof time. As another example, conventional systems and methods do nothave the capability to compare different pain maps or differentstimulation maps that are acquired at different points in time. As yet afurther example, conventional systems and methods are not capable ofproducing an intuitive and user-interactive pain map and stimulation mapoverlap coverage. As such, a healthcare professional may not be able toeffectively diagnose and treat the target patient.

To overcome these problems associated with existing electronicprogrammers discussed above, the present disclosure offers a programmerthat allows for the generation and display of a migration history ofpain maps and/or stimulation maps over time. The migration history maybe displayed as a time-lapse video or animation sequence in someembodiments. The time-lapse video or animation sequence fullyillustrates how the boundaries of the pain map and/or stimulation mapmove over time, along with the changing of the time or date information.In this manner, the healthcare professional can accurately determine howthe pain or stimulation has evolved in the past and how they are likelyto evolve in the future. Therefore, the healthcare professional candevelop a better treatment plan for the patient. The various aspects ofthe generation and display of the migration history of thepain/stimulation maps are discussed in more detail below.

FIG. 1 is a simplified block diagram of one embodiment of a medicaldevice system 20 to provide an example context for the various aspectsof the present disclosure. The embodiment of the medical system 20includes an implantable medical device 30, an external charger 40, apatient programmer 50, and a clinician programmer 60. The implantablemedical device 30 can be implanted in a patient's body tissue. In theillustrated embodiment, the implantable medical device 30 includes animplanted pulse generator (IPG) 70 that is coupled to one end of animplanted lead 75. The other end of the implanted lead 75 includesmultiple electrode surfaces 80 through which electrical current isapplied to a desired part of a body tissue of a patient. The implantedlead 75 incorporates electrical conductors to provide a path for thatcurrent to travel to the body tissue from the IPG 70. Although only oneimplanted lead 75 is shown in FIG. 1, it is understood that a pluralityof implanted leads may be attached to the IPG 70.

Although an IPG is used here as an example, it is understood that thevarious aspects of the present disclosure apply to an external pulsegenerator (EPG) as well. An EPG is intended to be worn externally to thepatient's body. The EPG connects to one end (referred to as a connectionend) of one or more percutaneous, or skin-penetrating, leads. The otherend (referred to as a stimulating end) of the percutaneous lead isimplanted within the body and incorporates multiple electrode surfacesanalogous in function and use to those of an implanted lead.

The external charger 40 of the medical device system 20 provideselectrical power to the IPG 70. The electrical power may be deliveredthrough a charging coil 90. In some embodiments, the charging coil canalso be an internal component of the external charger 40. The IPG 70 mayalso incorporate power-storage components such as a battery or capacitorso that it may be powered independently of the external charger 40 for aperiod of time, for example from a day to a month, depending on thepower requirements of the therapeutic electrical stimulation deliveredby the IPG.

The patient programmer 50 and the clinician programmer 60 may beportable handheld devices that can be used to configure the IPG 70 sothat the IPG 70 can operate in a certain way. The patient programmer 50is used by the patient in whom the IPG 70 is implanted. The patient mayadjust the parameters of the stimulation, such as by selecting aprogram, changing its amplitude, frequency, and other parameters, and byturning stimulation on and off. The clinician programmer 60 is used by amedical personnel to configure the other system components and to adjuststimulation parameters that the patient is not permitted to control,such as by setting up stimulation programs among which the patient maychoose, selecting the active set of electrode surfaces in a givenprogram, and by setting upper and lower limits for the patient'sadjustments of amplitude, frequency, and other parameters.

In the embodiments discussed below, the clinician programmer 60 is usedas an example of the electronic programmer. However, it is understoodthat the electronic programmer may also be the patient programmer 50 orother touch screen programming devices (such as smart-phones or tabletcomputers) in other embodiments.

FIGS. 2, 3A-3B, 4A-4B, 5A-5B, and 6-15 are example screenshots of a userinterface 100 for generating and displaying sensation maps (e.g.,pain/stimulations maps) according to the various aspects of the presentdisclosure. In some embodiments, the user interface 100 may be displayedon a screen of a programmer. In some embodiments, the screen may be acapacitive or resistive touch-sensitive screen. In other embodiments,the screen may be a non-touch-sensitive screen, for example aLiquid-Crystal Display (LCD) screen, a Light-Emitting Diode (LED)screen, or a Cathode Ray Tube (CRT) screen. In yet other embodiments,the user interface 100 may be displayed on a programmer and an externalmonitor simultaneously, for example in accordance with U.S. patentapplication Ser. No. 13/600,875, filed on Aug. 31, 2012, entitled“Clinician Programming System and Method”, attorney docket46901.11/QIG068, the disclosure of which is hereby incorporated byreference in its entirety. As such, both the healthcare provider and thepatient are able to view the user interface at the same time.

Referring to FIG. 2, the user interface 100A illustrates a 3D model of ahuman body 110. The 3D human body model 110 includes an entire humanbody, though the user interface 100 may be configured to view only aportion of the human body model 110 at a time. The human body model 110can also be moved in all directions, rotated, resized, or otherwisemanipulated. In some embodiments, the human body model 110 is customizedfor a specific patient. For instance, if a patient is tall (e.g., 6 feetor taller), the human body model 110 may be created (or later resized)to be “taller” too, so as to correspond with the patient's height. Asanother example, if the patient is overweight or underweight, the humanbody model 110 may be created (or later resized) to be wider ornarrower, so as to correspond with the patient's weight. As otherexamples, if the patient has particularly long or short limbs (or evenmissing limbs or body parts), hands/feet, or a specific body build, thehuman body model 110 may be created (or later resized) to correspondwith these body characteristics of the patient as well.

In some embodiments, the present disclosure offers a database thatincludes a plurality of predefined human body models that eachcorrespond to a specific body type, for example a predefined body typefor a 40 year old Caucasian male with a height of 6′1 and a weight of200 pounds, or a 20 year old African American female with a height of5′5 with a weight of 120 pounds, so on and so forth. In theseembodiments, a healthcare professional or the patient can quickly selecta predefined body type from this database that most closely matcheshis/her physical conditions/characteristics. In this manner, thehealthcare professional need not spend too much time specificallycustomizing the human body model 110 to the patient, since a predefinedhuman body model that is substantially similar to the patient is alreadyavailable from the database. It is also understood that such databasemay be available to a network of healthcare professionals and may bedownloaded to the electronic programmer upon verifying the necessarylogin credentials. The patient models may also be uploaded from anelectronic programmer to the database. In some further embodiments, theclinician programmer discussed herein is configured to capture an imageof the patient (for example via an integrated camera). The proportionsand other bodily details of the patient may then be automaticallyadjusted by processing the captured patient image.

FIGS. 3A-5A, 3B-5B, and 6-9 are graphical examples illustrating how ahuman body model can be customized to more accurately match the physicaltraits of a patient. In more detail, FIGS. 3A-3B are graphicalillustrations of an implanted medical device (e.g., a paddle lead)relative to a spine of a patient. In FIG. 3A, the patient is a shortpatient, and therefore the implanted medical device covers more vertebralevels. In comparison, the patient is a tall patient in FIG. 3B, andthus the implanted medical device covers fewer vertebra levels. This isbecause the spacing between the vertebra levels increase as thepatient's height increases, but the length of the implanted medicaldevice will remain the same regardless of the patient's height. Thus,FIGS. 3A-3B highlight the importance of matching the actual patient witha model as closely as possible, as the efficacy of the treatment isdependent on the accurate modeling.

As discussed above, height is not the only variable that can be adjustedin customizing a human body model that closely matches the actualpatient. Gender and weight are also among the variables that can beadjusted. As examples, FIG. 4A illustrates a standard male model, FIG.4B illustrates a standard female model, FIG. 5A illustrates a tall andthin female model, and FIG. 5B illustrates a short and more heavy-setfemale model. Furthermore, another possible structural adjustment is theremoval of appendages, which is illustrated in FIG. 6, where the modelis missing a part of his left arm. The removal of appendages may beaccomplished by not using all the vertices of the original model, forexample. And although not specifically shown for reasons of simplicity,other variables that can be adjusted include skin color, hair color, eyecolor, etc.

FIG. 7 is an example patient information record in which the user (whomay or may not be the patient) may enter patient specifics such asheight, weight, gender, body type, etc. discussed above. In someembodiments, the patient record may be used to automatically modify thehuman body model representing the actual patient. In other embodiments,the user may manually adjust the human body model manually. In yet otherembodiments, the user may make manual adjustments to the human bodymodel after a human body model has been automatically generated based onthe patient information entered into the patient record. For example, inFIG. 8, a standard male model has been generated for patient “John S.Doe” based on the data entered into his patient record. The user wantsto make further manual adjustments to the automatically-generated model,and thus a list of modification options appears, which includes “AdjustHeight,” “Adjust Weight,” “Adjust Skin Color,” “Adjust Hair,” and“Adjust Body Type.” The user wishes to make an adjustment to the bodytype and selects the option “Adjust Body Type.” As a result, a list ofbody type options appears, which includes “Ectomorph” (heavy/rounded),“Endomorph” (lean), and “mesomorph” (muscular).

Referring now to FIG. 9, an adjusted model is shown as a result of theuser selecting “Ectomorph.” Thus, the model is FIG. 9 is heavier andmore rounded compared to the model in FIG. 8 before the adjustment. Ofcourse, these adjustment options discussed above are merely examples,and additional adjustment options are envisioned in other embodiments.

Referring now back to FIG. 2, the user interface 100 also displays aplurality of menu items 120-127 to assist with the generation anddisplay of the pain maps and stimulation maps (not visible in FIG. 2).The display of the menu items 120-127 is triggered by the user pressingon a virtual button 128. In the illustrated embodiment, the menu item120 is used to generate a pain map or a stimulation map. After selectingthe menu item 120, the patient can user his/her finger(s) as a simulatedbrush to draw or paint an area on the human body model 110 thatcorresponds to a region of pain the patient experiences. For example, ifthe patient feels pain in his/her shoulder, he/she can paint a pain mapon the shoulder region of the human body model 110. The human body model110 can also be rotated, so that the patient can paint the pain map indifferent regions of the human body model. The patient may revise thepain map to correspond as closely with the actual perceived regions ofpain as possible. To facilitate the painting/drawing of the pain maps,the simulated brush may be of adjustable size.

The stimulation map may be created in a similar manner, except that thestimulation map corresponds with the perceived stimulation (e.g.,Paresthesia) experienced by the patient. The pain map and stimulationmap are drawn on a touch-sensitive screen in the illustrated embodiment,but may be drawn via any other suitable type of user interface in otherembodiments. A graphics accelerator may be used to speed up thegeneration of these maps.

Once the virtual button 128 is engaged to trigger the display of themenu items 120-127, the menu items 120-121 may be used to indicatedifferent levels of intensity of the pain or stimulation. For example,referring to FIG. 10, after the menu item 120 is used to create a“baseline” pain map that covers a region of the body in general, themenu item 121 (shown in FIG. 2) may be used to indicate a region wherethe pain is more intense. In the embodiment shown in FIG. 10, thepatient may draw a region 140 as a “baseline” pain region to indicategeneral pain. This region 140 may represent the body regions where thepatient feels some degree of pain. The patient may also draw a region142 within the region 142 as an “intense” or “acute” pain region. Inother words, the patient may feel much more pain in the region 142 thanin the rest of the region 140. The degree of the pain intensity maycorrespond with a color (or hue) of the region, and a variety of colorsmay be available to represent different degrees of pain.

Thus, a pain map of the present disclosure may reveal various regionswith different degrees of pain. In some embodiments, the more painfulregions are represented by darker colors, and the less painful regionsare represented by lighter colors. The opposite may be true in otherembodiments. In further embodiments, various pain maps may be created torepresent different types of pain, for example a numbness, a burningpain, a tingling, a soreness, etc. These different types of pain may berepresented by pain maps with different colors or different textures,for example. In yet other embodiments, the depth of pain (whether thepain is only skin-deep or penetrates to the muscle level) may also berepresented by the pain maps, for example by different colors ordifferent textures of the pain maps. It is also understood that thepain/stimulation maps may be resized proportionally to automaticallycorrespond with the underlying human body model. That is, if the humanbody model on which the pain/stimulation maps are resized, thepain/stimulation maps may be resized accordingly.

Similarly, the patient may also draw a region 150 to indicate a regionon the body where the patient experiences stimulation while thestimulation therapy is active. The stimulation maps may be configured ina similar manner as the pain maps. In other words, the stimulation mapsmay be configured to portray different intensities of stimulationsensations, different regions of stimulation sensations, different typesof stimulation sensations or different depths of stimulation sensations.Note that the pain region 140 and the stimulation region 150 may bedisplayed individually, or simultaneously, as shown in FIG. 10. Anoverlapping region 155 (an overlapping between the pain region 140 andthe stimulation region 150) may also be displayed, which is helpful inhelping the healthcare professional in diagnosing and treating thepatient.

It is understood that although pain maps are used as an example hereinfor illustration purposes, stimulation maps containing regions withdifferent stimulation intensity may be generated in the same manner.

Referring back to FIG. 2, the menu item 122 is used to erase or removeportions of the pain map or the stimulation map. This is done when thepatient needs to revise an existing pain map or stimulation map, forexample when the pain map or stimulation map is dated and no longeraccurately reflects the patient's perceived pain or stimulation.

The menu item 123 is used to delete an existing pain map or stimulationmap.

The menu item 124 is used to cycle through different maps, such asswitching between pain maps and stimulation maps.

The menu item 125 is used to generate a new pain map or a newstimulation map (or updated versions of existing pain/stimulation maps).

The menu item 126 is used to save changes to a pain map or a stimulationmap.

The menu item 127 is used to play back a migration of pain maps andstimulation maps, or a combination thereof. The migration of the painmaps and stimulation maps may be historical (i.e., in the past) orprojected (i.e., in the future). Among other things, this may be used toshow progression of treatment.

Of course, these menu items 120-127 are merely examples. Some of thesemenu items may be removed, and other menu items may be added inalternative embodiments to carry out the generation and editing of thepain map and stimulation map.

The present disclosure also allows for predefined pain or stimulationregions. For example, referring now to FIG. 11, the user interface 100Cshows a plurality of menu items 160-167 that each correspond to apredefined pain or stimulation region on the human body model 110. Forexample, in the embodiment shown, the menu item 160 may correspond to apredefined pain region in the right arm of the patient; the menu item161 may correspond to a predefined pain region in the left arm of thepatient; the menu item 162 may correspond to a predefined pain region inthe waist and thighs of the patient; the menu item 163 may correspond toa predefined pain region in the abdomen of the patient; the menu item164 may correspond to a predefined pain region in the right lower leg ofthe patient; the menu item 165 may correspond to a predefined painregion in the lower left leg of the patient; the menu item 166 maycorrespond to a predefined pain region in the right foot of the patient;and the menu item 167 may correspond to a predefined pain region in theleft foot of the patient. In certain embodiments, the severity orintensity of pain/stimulation, type of pain/stimulation, and depth ofpain/stimulation may be selected as a part of the predefined regions.

In the embodiment shown in FIG. 11, the menu item 166 is selected, whichautomatically generates a pain region 170 that covers the right foot ofthe human body model 110. The pain region 170 can then be revised by thepatient to create a pain map that more accurately matches with the painexperienced by the patient. In the same manner, a predefined stimulationregion may be automatically generated and then revised to create adesired stimulation map.

The correlations between stimulation parameters (e.g., milliamps,polarity, pulse width, frequency, lead position) or activity parameters(e.g., sitting, standing, sleeping, running, etc.) and perceivedstimulation maps are a valuable part of map analysis, because theyindicate the degree to which a parameter is related to a certain effect.Map correlations, which can be carried out between individualstimulation programs (“programs”) and effective or perceived stimulationmaps, are also possible between groups of programs (“programs sets”) andan effective stimulation map. A more detailed discussion of stimulationparameters, programs and program sets is found in U.S. patentapplication Ser. No. 13/601,631, filed on Aug. 31, 2012, and entitled“Programming and Virtual Reality Representation of Stimulation ParameterGroups” to Norbert Kaula, et al., the content of which are herebyincorporated by reference in its entirety. Note that in someembodiments, the “program sets” may also be referred to as “programs”while the “programs” may be referred to as “sub-programs.”

According to various aspects of the present disclosure, the human bodymodel used to generate the pain map and stimulation map may also have aplurality of predefined starting locations for the user to choose from.FIGS. 12-13 illustrate some of these predefined starting locations asexamples. As shown in FIGS. 12-13, a user interface 100D illustrates aplurality of icons 200-207. Each of the icons 200-207 corresponds to aparticular portion of the human body model. As the user clicks on aparticular one of the icons 200-207, the corresponding portion of thehuman body model will be selected as the starting locations for thehuman body model on which a stimulation map and/or a pain map and bedrawn.

For example, as shown in FIG. 12, the icon 204 in the illustratedembodiment corresponds to the “right hand” of the human body model 110shown in the user interface 100. In response to a user's click of theicon 204, the human body model 110 is automatically adjusted (e.g.,rotated) to have the right hand of the human body model 110 face theuser. In other words, the right hand of the human body model 110 isbrought to the front and center of the screen for pain maps orstimulation maps to be painted thereon.

As another example, the icon 202 in the illustrated embodimentcorresponds to the “head” of the human body model 110 shown in the userinterface 100D. Referring to FIG. 13, in response to a user's click ofthe icon 202, the human body model 110 is automatically adjusted (e.g.,rotated) to have the head of the human body model 110 face the user. Inother words, the head of the human body model 110 is brought to thefront and center of the screen for pain maps or stimulation maps to bepainted thereon.

In each of the examples discussed above, a target starting location (forthe generation of pain/stimulation maps) is automatically provided forthe user in a quick and convenient manner. It is understood that theuser may also manually manipulate the human body model 110—for exampleby rotating, moving, or resizing it—to arrive at a desired targetstarting location to generate the pain map or stimulation map. But thatmanual process takes more time, whereas the available predefinedstarting locations offer more convenience for the user and thereby makethe pain/stimulation map generation process more user friendly.

According to the various aspects of the present disclosure, theclinician programmer can also provide a visualization of a migrationhistory of the pain maps and stimulation maps. In more detail, the painmaps and stimulation maps as discussed above can be stored in anelectronic memory, for example in an electronic database or another typeof permanent or erasable memory storage structure. For each pain mapand/or stimulation map, its respective date information (e.g., the dateon which the pain map or the stimulation map is generated or created) isstored along with the pain map or stimulation map in the database. Basedon such information stored in the database, a comparison between acurrent pain/stimulation map may be generated with an originalpain/stimulation map. The comparison may include a visual coverageoverlap between the two maps and/or may include a numerical value (e.g.,in terms of percentages) for the increase or decrease inpain/stimulation coverage.

In some embodiments, the database resides on the clinician programmeritself. In some other embodiments, the database resides on a remoteserver, i.e., the cloud. In yet some other embodiments, the databaseresides on an implantable medical device, for example an implantablepulse generator (e.g., on the IPG 30 in FIG. 1). It is also understoodthat the electronic database, or a portion thereof, may besimultaneously stored in more than just one location. For example,different copies of the electronic database (or portions thereof) may besimultaneously stored in the clinician programmer, the remote server,and the implantable medical device.

Such database of pain/stimulation maps allows for a visualization of amigration history of pain maps or stimulation maps over time. Forexample, referring to FIGS. 14-15, the user interface 100E may display avirtual control mechanism 220 to visually indicate a pain map at aplurality of time slots in order to illustrate the migration history ofthe pain/stimulation map. In the illustrated embodiment, the virtualcontrol mechanism 220 includes a slider bar 230, a marker 235 on theslider bar 230, and a virtual play button 240. The marker 235 can bemoved in a horizontal direction along the slider bar 230, for examplefrom the left of the screen toward the right, or vice versa. A length ofthe slider bar 230 may correspond to or represent a predefined timeperiod, for example X years, months, weeks, or days. As such, theposition of a marker 235 on the slider bar 230 corresponds to thepain/stimulation map at a particular point in time. For instance, in theillustrated embodiment, as the marker 235 is moved from the left to theright along the slider bar 230, more and more recent pain maps areretrieved from the database and displayed by the user interface 100E.

FIGS. 14-15 illustrate two example pain maps 250-251 that correspond todifferent points in time as the virtual control mechanism 220 isengaged. In FIG. 14, the pain map 250 is acquired or generated on Apr.2, 2012, whereas the pain map 251 shown in FIG. 15 is acquired orgenerated on May 2, 2013. When the user drags the marker 235 to a firstposition on the slider bar 230 as shown in FIG. 14, (where the firstposition on the slider bar 230 corresponds to Apr. 2, 2012) the userinterface 100E retrieves the pain map 250 that is captured on Apr. 2,2012 from the database. When the user drags the marker 235 to a secondposition on the slider bar 230 as shown in FIG. 15, (where the secondposition on the slider bar 230 corresponds to May 2, 2013) the userinterface 100E retrieves the pain map 251 that is captured on May 2,2013 from the database.

A plurality of other pain maps and/or stimulation maps is stored in theelectronic database discussed above in addition to the pain maps 250-251illustrated herein. In other words, a plurality of otherpain/stimulation maps may have been generated between Apr. 2, 2012 andMay 2, 2013 (or before Apr. 2, 2012, and after May 2, 2013) and arestored in the electronic database, but they are not specificallyillustrated herein for reasons of simplicity. Nevertheless, it isunderstood that as the user drags the marker 235 from the left on theslider bar 230 to the right, the user interface 100 is continuouslyupdated with more and more recent pain maps (i.e., retrieved from thedatabase) that are visually displayed. Similarly, if the user drags themarker 235 from the right to the left on the slider bar 230, the userinterface 100 would be continuously updated with older pain maps fromthe past. Since the updating occurs almost instantaneously (e.g., withina fraction of a second), the user may be presented with a visualmigration history of the pain/stimulation maps as the user moves themarker 235 to the left or right on the slider bar 230. Note that theuser interface 100E also displays a date 250 for the pain map 250 and adate 251 for the pain map 251. The dates 250-251 may further assist thehealthcare professional in making an accurate diagnosis and/orformulating a treatment plan for the patient. For example, in someembodiments, each pain map or stimulation map may be electronicallyassociated with a particular stimulation therapy (e.g., made up of oneor more stimulation programs or program sets). In this manner, if thepatient reports an increase in pain when the stimulation therapy changes(e.g., from therapy 1 to therapy 2), then the healthcare professionalmay revert back to the old therapy (e.g., therapy 1) that offered morepain relief.

It is also understood that the user may automate the display of themigration history of pain/stimulation maps by engaging the virtual playbutton 240. For example, once the user clicks on the virtual play button240, the user interface 100E will continuously display all the pain mapsand/or stimulation maps that exist in the predefined time periodcorresponding to the length of the slider bar 230, however long thattime period may be. These pain/stimulation maps may be displayed in achronological sequence, for example from the oldest to the most recent.Each one of the pain/stimulation maps may be displayed for a predefinedperiod of time on the screen (e.g., for one or more seconds or afraction of a second) before the next one is displayed. Of course, themarker 235 is automatically moved along the slider bar 230 “in sync”with the display of the pain/stimulation maps, so that the position ofthe marker 235 is indicative of the time at which the displayedpain/stimulation map is captured throughout the automated display.

In some embodiments, the automatic display of the plurality ofpain/stimulation maps in the chronological order may be performed in amanner such that it appears as a smooth time-lapse video or animation tothe user. This may be done by configuring the amount of time at whicheach pain/stimulation map is displayed on the screen, which can becarried out by the user. In some embodiments, the animation or videowill be played in its entirety in the absence of further user input. Inother words, once the user presses the virtual play button 240, theanimation sequence of the pain/stimulation maps will be played in itsentirety (corresponding to a time period equal to the length of theslider bar 230). The user may also choose to interrupt the playing ofthe animation sequence by further engagements with the virtual controlmechanism 220, for example pausing the playing of the animation sequenceby clicking on the virtual play button 240, or reverting to manualcontrol by clicking and dragging the marker 235 along the slider bar230.

Based on the above discussions, it can be seen that the user can easilyview and interpret the migration history of the pain/stimulation maps,which represent the change of the pain/stimulation experienced by thepatient over time. The visualization of the pain/stimulation mapmigration history is intuitive for the user and allows him/her toformulate a more effective treatment plan for the patient accordingly.It is understood that although a single pain map (e.g., 250 or 251) isused here to visually illustrate an example migration history,stimulation maps may be superimposed on the human body model 110 alongwith the pain maps 250/251. In other words, the pain maps 250-251 may besimultaneously displayed with their corresponding stimulation maps(i.e., the pain map and stimulation map are obtained or generated at thesame time). The simultaneous visualization of the migration history ofthe pain map and stimulation map further facilitates the diagnosis andtreatment of the patient's pain.

Note that the virtual control mechanism 220 is used herein simply as oneexample for controlling the visual display of the migration history ofpain/stimulation maps. In alternative embodiments, other suitable typesof control mechanisms may be used, for example fast-forward or rewindbuttons/arrows, or virtual toggles, switches, or dials, each of whichmay be used to allow the user “navigate” through time. In some otherembodiments, the user may also manually enter a particular point in timeand retrieve the pain/stimulation map to correspond with that timemanually for display by the user interface 100E.

It is also understood that though the virtual control mechanism 220discussed above is used in the context of a touch-sensitive userinterface, it may be used in a non-touch-sensitive user interface aswell. In some embodiments, the user interface may include a mouse and/ora keyboard, which may be used to engage or otherwise manipulate thevirtual control mechanism 220 as well. For example, the user may use themouse to click on the marker 235 and drag it along the slider bar 230,or use the arrow keys on the keyboard to perform the same task.

According to the various aspects of the present disclosure, theclinician programmer can also display multiple maps simultaneously orconcurrently. The multiple maps may be the same type of maps (e.g., bothbeing pain maps or both being stimulation maps), or they may bedifferent types of maps (e.g., a pain map and a stimulation map). Thesimultaneous display of multiple maps also includes an overlap regionbetween the two maps, which may allow the user (e.g., a healthcareprofessional) to visualize the effectiveness of a stimulation therapy.

For example, referring now to FIG. 16, after a pain map and astimulation map have been generated, a user interface 100F can be usedto illustrate an overlap region 280 between the pain map and thestimulation map. The overlap region 280 is a region of the body that iscovered by both the pain map (indicating that the patient feels pain inthe region) and the stimulation map (indicating that the patient feels astimulation sensation in the region). The user interface 100F alsodisplays a numeric value 290 that represents an overlap coverage. Insome embodiments, the numeric value 290 is calculated as a size of theoverlap region 280 divided by a size of the pain map. Thus, the numericvalue 290 may vary from 0% to 100%. In the example shown in FIG. 16, thenumeric value 290 is 93.26%, which indicates that the 93.26% of the painmap is covered by the stimulation map.

It is desirable to have a close match between the pain map and thestimulation map, as that may indicate an optimal and efficient treatment(by stimulation) of the pain areas for the patient. In other words, aperfect match (e.g., 100%) between a pain map and a stimulation mapindicates that every area of pain has been stimulated to provideParesthesia in these areas, but no stimulation has been applied to areaswhere the patient does not feel pain. However, in real life situations,that is often not the case. Sometimes, the electrical stimulationtherapy generates a stimulation sensation outside of the patient's painareas. These “extra” areas of stimulation are unnecessary and may causediscomfort for the patient. Therefore, the clinician programmer may alsovisually represent such excessively stimulated areas, such as in a userinterface 100G shown in FIG. 17 discussed below.

Referring to FIG. 17, the user interface 100G visually illustrates apain map 300 and a stimulation map 305 concurrently on the human bodymodel 110. In some embodiments, the pain map 300 and the stimulation map305 may be given different visual characteristics, such as differentcolors or different types of shading, etc. In the embodiment shown inFIG. 17, the pain map 300 and the stimulation map 305 have differentcolors.

As can be seen in FIG. 17, the pain map 300 is also disposed entirelywithin, or wholly surrounded by, the stimulation map 305. Thus, theoverlap region of the pain map 300 and the stimulation map 305 in thisexample is the same as the pain map 300 itself. Consequently, thenumeric value 290 indicating the overlap coverage is 100%. However, thisexample does not represent a perfect match between the pain andstimulation maps, since portions of the stimulation map 305 are locatedoutside the pain map 300. These extra or excessive areas of stimulationmay cause discomfort for the patient and therefore should be minimizedor reduced.

In order to make the user professional aware of the “extra” stimulationareas, the user interface 100G displays a symbol 310 next to the numericvalue 290 to visually indicate the existence of excessive stimulation.In the illustrated embodiment, the symbol 310 is a “+” sign. In otherembodiments, symbol 310 may be another other intuitive symbol, or evenplain text indicating the existence of excessive stimulation. It isunderstood that excessive stimulation areas may still exist even if theoverlap coverage between pain and stimulation maps is less than 100%.That is, as long as a portion of a stimulation map lies outside of apain map, excessive stimulation exists, which may be indicated by thesymbol 310.

In some embodiments, the excessive stimulation areas may be selectivelydisplayed or visually highlighted. For example, referring now to FIG.18, a user interface 100G may be configured to “hide” the pain map 300and the portion of the stimulation map 305 that is overlapping with thepain map 300. In other words, the user interface 100G is now onlydisplaying a portion 305A of the stimulation map 305 that is outside thepain map 300, i.e., the area of excessive stimulation. In this manner,the user may quickly identify the excessive stimulation areas anddevelop plans to minimize these areas accordingly.

The selective display of the area of excessive stimulation may beperformed via a suitable user input through the user interface 100G. Forexample, in embodiments where the user interface 100G is provided on atouch-sensitive screen, the user may double tap (with a finger or astylus) on the excessive stimulation area 305A to selectively display it(and hide the rest of the stimulation map 305 and the pain map 300). Inalternative embodiments, the user may also double tap the overlap regionof the pain map 300 and the stimulation map 305 to hide it, which alsoallows the excessive stimulation area 305A to be selectively displayed.Of course, it is understood that the double tap may be replaced by othersuitable user inputs, such as a tap-and-hold input, or a double click(or even a single click) of a mouse, or a click of a virtual button 315,which may be programmed to toggle the selective display of the excessivestimulation area 305A on or off.

Similarly, in various other embodiments, areas of pain that are notcovered by the stimulation map may also be selectively displayed orvisually highlighted, for example by “hiding” the stimulation map aswell as portions of the pain map that overlaps with the stimulation map.For example, referring now to FIG. 19, a user interface 100H illustratesan example pain map 320 and an example stimulation map 325 on the humanbody model 110. The pain map 320 and the stimulation map 325 have anoverlap region 330 (i.e., covered by both the pain map 320 and thestimulation map 325). It can be seen that the overlap region 330 in thisembodiment is represented by a color that is a mix of the colors of thepain map 320 and the stimulation map 325.

Referring now to FIG. 20, in response to a suitable user engagement withthe user interface 100H, a portion 320A of the pain map 320 that is notcovered by the stimulation map 325 may be selectively displayed. Stateddifferently, the rest of the pain map 320 as well as the stimulation map325 may be hidden in response to the user engagement. In this manner,the user may quickly identify the pain areas that still need to betreated, and accordingly the user may develop plans to providestimulation coverage for such inadequately stimulated areas. Again, theuser engagement may be a double tap, a single tap, a tap-and-hold, asingle click or a double click of the mouse, or a click of the virtualbutton 315, etc. Conversely, this suitable user engagement may also beperformed to selectively display a portion of the stimulation that isnot overlapping with a pain map. In other words, the excess stimulationareas may be identified in this manner, so that the user may determinehow to configure or adjust the stimulation parameters to reduce theexcess (unwanted) stimulation.

According to various aspects of the present disclosure, the pain andstimulation maps may also be weighted differently. Referring now toFIGS. 21-22, a user interface 100I displays on the human body model 110a pain map 350, a stimulation map 355, and an overlap region 360 of thepain map 350 and the stimulation map 355. As discussed above, the userinterface 100I may display an overlap coverage as a numeric value 290,which in this case is 61.6%. In the illustrated embodiment, the numericvalue 290 may be calculated by dividing a size of the overlap region 360of the pain and stimulation maps by a size of the pain map 350. Also,since a portion of the stimulation map 355 lies outside the pain map350, it indicates the presence of excessive stimulation, which isrepresented by the display of the symbol 310 (e.g., “+” sign).

In some embodiment, the weighting of the pain map 350 and thestimulation map 355 may include visually emphasizing one of these mapswhile simultaneously de-emphasizing the other. For example, the pain map350 and the stimulation map 355 may each have an adjustable transparencylevel (or opaqueness level). By simultaneously adjusting the respectivetransparency levels of the pain map 350 and the stimulation map 355 inopposite manners, the pain map 350 may be visually emphasized bydecreasing its transparency level, while the stimulation map 355 may bevisually de-emphasized by increasing its transparency level, or viceversa.

To carry out the simultaneous adjustment of the respective visualemphasis of the pain map 350 and the stimulation map 355, the userinterface 100I may utilize a virtual control mechanism 370 that can beengaged by the user. In the embodiment shown in FIGS. 21-22, the virtualcontrol mechanism 370 includes an elongate slider bar 375 and a marker380 that can be moved along the slider bar 375 in response to a userengagement. For example, the marker 380 may be dragged along the sliderbar 375 via a touch-sensitive input in some embodiments, or via a mouseor a keyboard (e.g., arrow keys) input in alternative embodiments. Asthe marker 380 moves along the slider bar 375 in an upward direction,the transparency level of the pain map 350 decreases, and thetransparency level of the stimulation map 355 increases. In this manner,the pain map 350 is visually emphasized while the stimulation map 355 isvisually de-emphasized. Conversely, as the marker 380 moves along theslider bar 375 in a downward direction, the transparency level of thepain map 350 increases, and the transparency level of the stimulationmap 355 decreases. In this manner, the pain map 350 is visuallyde-emphasized while the stimulation map 355 is visually emphasized.

Using FIGS. 21-22 as an example, it can be seen that the position of themarker 380 is located near a bottom end of the slider bar 375 in FIG.21, which corresponds to a more transparent pain map 350 and a moreopaque stimulation map 355. In FIG. 22, the marker 380 has been moved upalong the slider bar 375, which corresponds to a more opaque pain map350 (i.e., less transparent) and a more transparent stimulation map 355.As such, it can be seen that the movement of the marker 380 along theslider bar 375 may be used to fade into one of the pain and stimulationmaps 350 and 355 and out of the other. This affords the user (e.g., ahealthcare professional) diagnostic versatility and flexibility, whichmay allow the user to quickly develop an effective treatment therapy forthe patient.

In some embodiments such as the one illustrated in FIGS. 21-22, inaddition to (or instead of) changing the respective transparency levelsof the pain and stimulation maps 350 and 355, the engagement of thevirtual control mechanism 370 may change the visual characteristics ofthe pain and stimulation maps 350 and 355 in other ways. For example,the movement of the marker 380 along the slider bar 375 may change therespective colors of the pain and stimulation maps 350 and 355, (e.g.,darken the color of one of them while lighten the color of the other).In some embodiments, as the coloring of the pain and stimulation maps350 and 355 changes along with the movement of the marker 380, thecoloring of the overlap region 360 may also be adjusted accordingly. Inaddition, in some embodiments such as the one illustrated in FIGS.21-22, the movement of the marker 380 also changes the visualcharacteristic (e.g., color or shading) of the slider bar 375 itself.For example, as the marker 380 is moved in a direction that increasesthe visual emphasis of the pain map 350, the color of the slider bar 375may shift to more closely match the color of the pain map 350 (and lessof the color of the stimulation map), and vice versa.

In some embodiments, the adjustment of the visual emphasis of the painand stimulation maps 350 and 355 may be performed such that only aportion (rather than an entirety) of these maps is visually emphasizedor de-emphasized. For example, as the marker 380 moves in a givendirection along the slider bar 375, the visual emphasis increases foronly the portion of the pain map 350 that is not covered by thestimulation map 355, while the visual emphasis decreases for only theportion of the stimulation map 355 that is not covered by the pain map350. In other words, the increase or decrease of the visual emphasis mayonly apply to the map regions outside the overlap region 360.Alternatively, the increase or decrease of the visual emphasis may onlyapply to the overlap region 360 as the marker 380 moves along the sliderbar 375.

It is understood that although the examples discussed above pertain tothe visual emphasis adjustment of a pain map and a stimulation map, thesame concept may be applied to two (or more) maps of the same type. Forexample, referring now to FIG. 23, two pain maps 390 and 391 areconcurrently displayed on the human body model 110. The two pain maps390-391 are visually differentiated from one another in a similar manneras the pain map 350 and the stimulation 355 discussed above, for examplewith different colors. In the illustrated embodiments, the pain maps390-391 are pain maps that are acquired from different points in time.For example, the pain map 390 is acquired on Feb. 1, 2011, and the painmap 391 is acquired on May 1, 2011. These dates may be displayedalongside their respective pain maps 390-391. In other embodiments, thepain maps 390-391 may be maps that are associated with differenttreatment protocols (e.g., pain maps created in response to differentstimulation programs, which may be around the same point in time). Inyet other embodiments, the pain maps 390-391 may be pain maps thatbelong to different patients. In a similar manner, two or morestimulation maps may be displayed concurrently on the human body model110. The concurrent display of two or more pain maps 390-391 or two ormore stimulation maps (and the corresponding overlap region between thetwo maps) offers the user additional medical information that can beused to develop a treatment therapy for the patient.

It is also understood that the virtual control mechanism 370 illustratedherein is merely an example, and it may be implemented differently inother embodiments and still provide the same or similar functionsdiscussed above. For example, the slider bar 375 may be horizontalrather than vertical, and it may be curved or rounded (e.g., in theshape of an arc or a semi-circle) rather than having a straight profileor a rectangular shape. As another example, the virtual controlmechanism 370 may be implemented with interactive virtual buttons, suchas arrow buttons that correspond to different directions, where theengagement of one of such arrows will increase the visual emphasis ofone of the maps while decreasing the other. As yet another example, thevirtual control mechanism 370 may be implemented as a virtual toggle,where the toggle can be pressed in a given direction (or the other) toincrease the visual emphasis of one of the maps while decreasing theother. As a further example, the virtual control mechanism 370 may beimplemented as a virtual dial, where the dial can turned/twisted/woundin a specific manner to increase the visual emphasis of one of the mapswhile decreasing the other. As one more example, the virtual controlmechanism 370 may be implemented as an alphanumeric input field, wherethe user can enter a number (or adjust an existing number) thatcorresponds to a specific respective visual emphasis of each of thedisplayed maps.

The present disclosure also allows the display and visual emphasisadjustment for one or more predefined regions on the human body model110, for example areas that are more important for pain management.Referring to FIG. 24, a user interface 100J may display another virtualcontrol mechanism 400. In the embodiment illustrated, the virtualcontrol mechanism 400 includes another slider bar 405 that is similar tothe slider bar 375, as well as another marker 410 that is similar to themarker 380. In other words, the marker 410 may be moved along the sliderbar 405 as well. Alternatively, the slider bar 405 may be “joined” withthe slider bar 375 such that the marker 380 may move onto the slider bar405, in which case the marker 410 may be eliminated. As such, thevirtual control mechanism 400 may be considered a part of the virtualcontrol mechanism 370 as well.

Referring now to FIG. 25, when the marker 380 moves along the slider bar400, the visual emphasis of an area of interest 420 may be adjustedaccordingly. In more detail, the area of interest 420 may be an area ofpain or area of stimulation that is important. For example, the area ofinterest 420 may be a particularly painful area, or an area ofstimulation that is particularly helpful in providing pain relief. Thepatient or the user may have previously defined this area of interest420. At a later time, it is possible that the area of interest 420 maybecome obfuscated or “lost in the shuffle” when the various pain andstimulation maps are displayed on the human body model 110. For example,the area of interest 420 is hardly visible in FIG. 24, which maycorrespond to a location of the marker 410 being at a top of the sliderbar 405. The poor visibility of the area of interest 420 may be due to ahigh visual emphasis of the stimulation map 355. In FIG. 25, as themarker 410 is moved toward a bottom direction along the slider bar 405,the predefined area of interest 420 is brought into focus progressively,i.e., its visual emphasis increases. Again, the visual emphasis increaseor decrease of this area of interest 420 may be accomplished byadjusting the transparency level, the color, or the shading of the areaof interest 420.

By visually emphasizing the area of interest 420, the user can bereminded of areas that are important for pain management and treatment,which may allow the user to develop more accurate and effectivetreatment therapies. It is also understood that the virtual controlmechanism 400 is provided merely as an example to illustrate how thearea of interest 420 may be displayed and have its visual emphasisadjusted. In alternative embodiments, virtual buttons, toggles, dials,etc. may also be used to accomplish the same tasks. For example, avirtual button 430 may be used to selectively turn on or off the area ofinterest 420.

FIG. 26 is a flowchart illustrating a method 500 of visualizing asensation experienced by a patient. The method 500 may be performed byan electronic device, such as by one or more electronic processors of aclinician programmer. The method 500 includes a step 505 of providing agraphical user interface configured to receive an input from a user anddisplay a visual output to the user. In some embodiments, the graphicaluser interface may include a touchscreen. In other embodiments, thegraphical user interface may include a keyboard, a mouse, or othersuitable input/output devices.

The method 500 includes a step 510 of displaying a virtual controlmechanism on the graphical user interface. In some embodiments, thedisplaying of the virtual control mechanism comprises displaying aslider bar and a marker configured to be moved along the slide bar,wherein a length of the slider bar corresponds to a predefined period oftime.

The method 500 includes a step 515 of detecting, through the graphicaluser interface, one or more engagements of the virtual controlmechanism. The virtual control mechanism may include a slider bar, amarker that can be moved along the slider bar, and a virtual playbutton. In some embodiments, the detecting of the one or moreengagements of the virtual control mechanism comprises detecting amovement of the marker along the slider bar.

The method 500 includes a step 520 of displaying, in response to theengagement of the virtual control mechanism, a sensation map history onthe graphical user interface. The sensation map history graphicallydepicts a migration of a sensation map over time on a virtual human bodymodel. In some embodiments, the step 520 includes displaying at leastone of: a pain map and a stimulation map. In some embodiments, thedisplaying of the sensation map history comprises automatically updatingthe sensation map history in response to the detected movement of themarker along the slider bar. In some embodiments, the updating of thesensation map history is performed such that the sensation map historyis updated to correspond with the detected movement of the marker alongthe slider bar in real time. In some embodiments, the displaying of thesensation map history comprises playing an animation sequence of aplurality of sensation maps. The sensation maps each graphically depictsa sensation experienced by the patient at a different point in time. Insome embodiments, the playing of the animation sequence comprisesdisplaying the plurality of sensation maps in a chronological order orin a reverse chronological order.

In some embodiments, the step 515 of detecting of the one or moreengagements of the virtual control mechanism comprises detecting a pressof the virtual button, in which case the playing of the animationsequence in step 520 comprises automatically playing, in response to thedetected press of the virtual button, the animation sequence in itsentirety in an absence of further user input.

It is understood that additional process steps may be performed before,during, or after the steps 505-520 discussed above. For example, in someembodiments, the method 500 may include a step of storing a plurality ofsensation maps in a memory. The sensation maps each graphically depictsa sensation experienced by the patient at a different point in time. Themethod 500 may also include a step of retrieving at least a subset ofthe plurality of sensation maps from the memory. In some embodiments,the step of storing of the sensation maps comprises storing respectivedate information to be associated with each of the sensation maps, andthe step of displaying the sensation map history comprises displayingthe respective date information associated with each of the sensationmaps. In some other embodiments, the method 500 may include a step ofsending the sensation map history to a remote server for a comparativeanalysis. The sending of the sensation map history may include removingprivate information of the patient associated with the sensation maphistory. Additional steps may be performed by the method 500, but theyare not specifically discussed herein for reasons of simplicity.

FIG. 27 is a flowchart illustrating a method 550 of displaying pain orstimulation experienced by a patient. The method 550 may be performed byan electronic device, such as by one or more electronic processors of aclinician programmer. The method 550 includes a step 555 of providing agraphical user interface configured to receive an input from a user anddisplay a visual output to the user. In some embodiments, the graphicaluser interface may include a touchscreen. In other embodiments, thegraphical user interface may include a keyboard, a mouse, or othersuitable input/output devices.

The method 550 includes a step 560 of concurrently displaying a firstmap and a second map via the graphical user interface. The first map andthe second map are each a pain map or a stimulation map. The pain maprepresents a body area of the patient experiencing pain. The stimulationmap represents a body area of the patient experiencing electricalstimulation. In some embodiments, the first map is a pain map, and thesecond map is a stimulation map. In some embodiments, the concurrentdisplay of the first map and the second map comprises displaying anoverlap region between the first map and the second map. In someembodiments, the step 560 may further include a sub-step of displaying anumerical value that indicates a size of the overlap region relative toa size of one of: the first map and the second map. In some embodiments,the step 560 may include a sub-step of displaying a sign if a portion ofthe stimulation map lies outside of the pain map. In some embodiments,the increasing or decreasing of the visual emphasis is only applied tothe overlap region.

In other embodiments, the first map and the second map are the same typeof maps. For example, they may both be pain maps, or they may both bestimulation maps. The same type of maps may be acquired from differentpoints in time, or acquired in response to different stimulationprograms, or acquired from different patients.

The method 550 includes a step 565 of displaying a virtual controlmechanism via the graphical user interface. In some embodiments, thestep 565 may include displaying an elongate slider bar and a markerconfigured to be moved along the slide bar. The detecting of the one ormore engagements of the virtual control mechanism comprises detecting amovement of the marker along the slider bar in one of a first directionand a second direction different from the first direction. Theincreasing of the visual emphasis of at least a portion of the first mapand the decreasing of the visual emphasis of at least a portion of thesecond map are performed in response to a detected movement of themarker along the slider bar in the first direction. The decreasing ofthe visual emphasis of at least a portion of the first map and theincreasing of the visual emphasis of at least a portion of the secondmap are performed in response to a detected movement of the marker alongthe slider bar in the second direction.

The method 550 includes a step 570 of detecting, through the graphicaluser interface, an engagement of the virtual control mechanism.

The method 550 includes a step 575 of adjusting, in response to theengagement of the virtual control mechanism, a respective visualemphasis of the first map and the second map. The step 575 may furtherinclude the following steps: increasing a visual emphasis of at least aportion of the first map while decreasing a visual emphasis of at leasta portion of the second map; or decreasing the visual emphasis of atleast a portion of the first map while increasing the visual emphasis ofat least a portion of the second map.

It is understood that additional process steps may be performed before,during, or after the steps 555-575 discussed above. For example, in someembodiments, the method 550 may include a step of adjusting a visualemphasis of a predefined region of one of the first and second maps. Forexample, the predefined region may include an area of interest that isimportant for pain management or treatment. Additional steps may beperformed by the method 550, but they are not specifically discussedherein for reasons of simplicity.

FIG. 28 shows a block diagram of one embodiment of the electronicprogrammer (CP) discussed herein. For example, the electronic programmermay be a clinician programmer (CP) configured to generate and displaythe migration history of pain/stimulation maps, or the concurrentdisplay of two or more maps (e.g., pain and stimulation maps or multiplemaps of the same type) discussed above. It is understood, however, thatalternative embodiments of the electronic programmer may be used toperform these tasks as well.

The CP includes a printed circuit board (“PCB”) that is populated with aplurality of electrical and electronic components that provide power,operational control, and protection to the CP. With reference to FIG.28, the CP includes a processor 600. The processor 600 controls the CP.In one construction, the processor 600 is an applications processormodel i.MX515 available from Free scale Semiconductor®. Morespecifically, the i.MX515 applications processor has internalinstruction and data caches, multimedia capabilities, external memoryinterfacing, and interfacing flexibility. Further information regardingthe i.MX515 applications processor can be found in, for example, the“IMX510EC, Rev. 4” data sheet dated August 2010 and published by Freescale Semiconductor® at www.freescale.com. The content of the data sheetis incorporated herein by reference. Of course, other processing units,such as other microprocessors, microcontrollers, digital signalprocessors, etc., can be used in place of the processor 600.

The CP includes memory, which can be internal to the processor 600(e.g., memory 605), external to the processor 600 (e.g., memory 610), ora combination of both. Exemplary memory include a read-only memory(“ROM”), a random access memory (“RAM”), an electrically erasableprogrammable read-only memory (“EEPROM”), a flash memory, a hard disk,or another suitable magnetic, optical, physical, or electronic memorydevice. The processor 600 executes software that is capable of beingstored in the RAM (e.g., during execution), the ROM (e.g., on agenerally permanent basis), or another non-transitory computer readablemedium such as another memory or a disc. The CP also includesinput/output (“I/O”) systems that include routines for transferringinformation between components within the processor 600 and othercomponents of the CP or external to the CP.

Software included in the implementation of the CP is stored in thememory 605 of the processor 600, RAM 610, ROM 615, or external to theCP. The software includes, for example, firmware, one or moreapplications, program data, one or more program modules, and otherexecutable instructions. The processor 600 is configured to retrievefrom memory and execute, among other things, instructions related to thecontrol processes and methods described below for the CP.

One memory shown in FIG. 28 is memory 610, which may be a double datarate (DDR2) synchronous dynamic random access memory (SDRAM) for storingdata relating to and captured during the operation of the CP. Inaddition, a secure digital (SD) multimedia card (MMC) may be coupled tothe CP for transferring data from the CP to the memory card via slot615. Of course, other types of data storage devices may be used in placeof the data storage devices shown in FIG. 28.

The CP includes multiple bi-directional radio communicationcapabilities. Specific wireless portions included with the CP are aMedical Implant Communication Service (MICS) bi-directional radiocommunication portion 620, a Wi-Fi bi-directional radio communicationportion 625, and a Bluetooth bi-directional radio communication portion630. The MICS portion 620 includes a MICS communication interface, anantenna switch, and a related antenna, all of which allows wirelesscommunication using the MICS specification. The Wi-Fi portion 625 andBluetooth portion 630 include a Wi-Fi communication interface, aBluetooth communication interface, an antenna switch, and a relatedantenna all of which allows wireless communication following the Wi-FiAlliance standard and Bluetooth Special Interest Group standard. Ofcourse, other wireless local area network (WLAN) standards and wirelesspersonal area networks (WPAN) standards can be used with the CP.

The CP includes three hard buttons: a “home” button 635 for returningthe CP to a home screen for the device, a “quick off” button 640 forquickly deactivating stimulation IPG, and a “reset” button 645 forrebooting the CP. The CP also includes an “ON/OFF” switch 650, which ispart of the power generation and management block (discussed below).

The CP includes multiple communication portions for wired communication.Exemplary circuitry and ports for receiving a wired connector include aportion and related port for supporting universal serial bus (USB)connectivity 655, including a Type A port and a Micro-B port; a portionand related port for supporting Joint Test Action Group (JTAG)connectivity 660, and a portion and related port for supportinguniversal asynchronous receiver/transmitter (UART) connectivity 665. Ofcourse, other wired communication standards and connectivity can be usedwith or in place of the types shown in FIG. 28.

Another device connectable to the CP, and therefore supported by the CP,is an external display. The connection to the external display can bemade via a micro High-Definition Multimedia Interface (HDMI) 670, whichprovides a compact audio/video interface for transmitting uncompresseddigital data to the external display. The use of the HDMI connection 670allows the CP to transmit video (and audio) communication to an externaldisplay. This may be beneficial in situations where others (e.g., thesurgeon) may want to view the information being viewed by the healthcareprofessional. The surgeon typically has no visual access to the CP inthe operating room unless an external screen is provided. The HDMIconnection 670 allows the surgeon to view information from the CP,thereby allowing greater communication between the clinician and thesurgeon. For a specific example, the HDMI connection 670 can broadcast ahigh definition television signal that allows the surgeon to view thesame information that is shown on the LCD (discussed below) of the CP.

The CP includes a touch screen I/O device 675 for providing a userinterface with the clinician. The touch screen display 675 can be aliquid crystal display (LCD) having a resistive, capacitive, or similartouch-screen technology. It is envisioned that multitouch capabilitiescan be used with the touch screen display 675 depending on the type oftechnology used.

The CP includes a camera 680 allowing the device to take pictures orvideo. The resulting image files can be used to document a procedure oran aspect of the procedure. Other devices can be coupled to the CP toprovide further information, such as scanners or RFID detection.Similarly, the CP includes an audio portion 685 having an audio codeccircuit, audio power amplifier, and related speaker for providing audiocommunication to the user, such as the clinician or the surgeon.

The CP further includes a power generation and management block 690. Thepower block 690 has a power source (e.g., a lithium-ion battery) and apower supply for providing multiple power voltages to the processor, LCDtouch screen, and peripherals.

In one embodiment, the CP is a handheld computing tablet with touchscreen capabilities. The tablet is a portable personal computer with atouch screen, which is typically the primary input device. However, anexternal keyboard or mouse can be attached to the CP. The tablet allowsfor mobile functionality not associated with even typical laptoppersonal computers. The hardware may include a Graphical Processing Unit(GPU) in order to speed up the user experience. An Ethernet port (notshown in FIG. 28) may also be included for data transfer.

It is understood that a patient programmer may be implemented in asimilar manner as the clinician programmer shown in FIG. 28.

FIG. 29 shows a block diagram of one embodiment of an implantablemedical device. In the embodiment shown in FIG. 29, the implantablemedical device includes an implantable pulse generator (IPG). The IPGincludes a printed circuit board (“PCB”) that is populated with aplurality of electrical and electronic components that provide power,operational control, and protection to the IPG. With reference to FIG.29, the IPG includes a communication portion 700 having a transceiver705, a matching network 710, and antenna 712. The communication portion700 receives power from a power ASIC (discussed below), and communicatesinformation to/from the microcontroller 715 and a device (e.g., the CP)external to the IPG. For example, the IPG can provide bi-direction radiocommunication capabilities, including Medical Implant CommunicationService (MICS) bi-direction radio communication following the MICSspecification.

The IPG provides stimuli to electrodes of an implanted medicalelectrical lead (not illustrated herein). As shown in FIG. 29, Nelectrodes are connected to the IPG. In addition, the enclosure orhousing 720 of the IPG can act as an electrode. The stimuli are providedby a stimulation portion 225 in response to commands from themicrocontroller 215. The stimulation portion 725 includes a stimulationapplication specific integrated circuit (ASIC) 730 and circuitryincluding blocking capacitors and an over-voltage protection circuit. Asis well known, an ASIC is an integrated circuit customized for aparticular use, rather than for general purpose use. ASICs often includeprocessors, memory blocks including ROM, RAM, EEPROM, FLASH, etc. Thestimulation ASIC 730 can include a processor, memory, and firmware forstoring preset pulses and protocols that can be selected via themicrocontroller 715. The providing of the pulses to the electrodes iscontrolled through the use of a waveform generator and amplitudemultiplier of the stimulation ASIC 730, and the blocking capacitors andovervoltage protection circuitry 735 of the stimulation portion 725, asis known in the art. The stimulation portion 725 of the IPG receivespower from the power ASIC (discussed below). The stimulation ASIC 730also provides signals to the microcontroller 715. More specifically, thestimulation ASIC 730 can provide impedance values for the channelsassociated with the electrodes, and also communicate calibrationinformation with the microcontroller 715 during calibration of the IPG.

The IPG also includes a power supply portion 740. The power supplyportion includes a rechargeable battery 745, fuse 750, power ASIC 755,recharge coil 760, rectifier 763 and data modulation circuit 765. Therechargeable battery 745 provides a power source for the power supplyportion 740. The recharge coil 760 receives a wireless signal from thePPC. The wireless signal includes an energy that is converted andconditioned to a power signal by the rectifier 763. The power signal isprovided to the rechargeable battery 745 via the power ASIC 755. Thepower ASIC 755 manages the power for the IPG. The power ASIC 755provides one or more voltages to the other electrical and electroniccircuits of the IPG. The data modulation circuit 765 controls thecharging process.

The IPG also includes a magnetic sensor 780. The magnetic sensor 780provides a “hard” switch upon sensing a magnet for a defined period. Thesignal from the magnetic sensor 780 can provide an override for the IPGif a fault is occurring with the IPG and is not responding to othercontrollers.

The IPG is shown in FIG. 29 as having a microcontroller 715. Generallyspeaking, the microcontroller 715 is a controller for controlling theIPG. The microcontroller 715 includes a suitable programmable portion785 (e.g., a microprocessor or a digital signal processor), a memory790, and a bus or other communication lines. An exemplarymicrocontroller capable of being used with the IPG is a model MSP430ultra-low power, mixed signal processor by Texas Instruments. Morespecifically, the MSP430 mixed signal processor has internal RAM andflash memories, an internal clock, and peripheral interfacecapabilities. Further information regarding the MSP 430 mixed signalprocessor can be found in, for example, the “MSP430G2x32, MSP430G2x02MIXED SIGNAL MICROCONTROLLER” data sheet; dated December 2010, publishedby Texas Instruments at www.ti.com; the content of the data sheet beingincorporated herein by reference.

The IPG includes memory, which can be internal to the control device(such as memory 790), external to the control device (such as serialmemory 795), or a combination of both. Exemplary memory include aread-only memory (“ROM”), a random access memory (“RAM”), anelectrically erasable programmable read-only memory (“EEPROM”), a flashmemory, a hard disk, or another suitable magnetic, optical, physical, orelectronic memory device. The programmable portion 785 executes softwarethat is capable of being stored in the RAM (e.g., during execution), theROM (e.g., on a generally permanent basis), or another non-transitorycomputer readable medium such as another memory or a disc.

Software included in the implementation of the IPG is stored in thememory 790. The software includes, for example, firmware, one or moreapplications, program data, one or more program modules, and otherexecutable instructions. The programmable portion 785 is configured toretrieve from memory and execute, among other things, instructionsrelated to the control processes and methods described below for theIPG. For example, the programmable portion 285 is configured to executeinstructions retrieved from the memory 790 for sweeping the electrodesin response to a signal from the CP.

Referring now to FIG. 30, a simplified block diagram of a medicalinfrastructure 800 (which may also be considered a medical system) isillustrated according to various aspects of the present disclosure. Themedical infrastructure 800 includes a plurality of medical devices 810.These medical devices 810 may each be a programmable medical device (orparts thereof) that can deliver a medical therapy to a patient. In someembodiments, the medical devices 810 may include a device of theneurostimulator system discussed above with reference to FIG. 1. Forexample, the medical devices 810 may be a pulse generator (e.g., the IPGdiscussed above with reference to FIG. 29), an implantable lead, acharger, or portions thereof. It is understood that each of the medicaldevices 810 may be a different type of medical device. In other words,the medical devices 810 need not be the same type of medical device.

The medical infrastructure 800 also includes a plurality of electronicprogrammers 820. For sake of illustration, one of these electronicprogrammers 820A is illustrated in more detail and discussed in detailbelow. Nevertheless, it is understood that each of the electronicprogrammers 820 may be implemented similar to the electronic programmer820A.

In some embodiments, the electronic programmer 820A may be a clinicianprogrammer, for example the clinician programmer discussed above withreference to FIG. 28. In other embodiments, the electronic programmer820A may be a patient programmer or another similar programmer. Infurther embodiments, it is understood that the electronic programmer maybe a tablet computer. In any case, the electronic programmer 820A isconfigured to program the stimulation parameters of the medical devices810 so that a desired medical therapy can be delivered to a patient.

The electronic programmer 820A contains a communications component 830that is configured to conduct electronic communications with externaldevices. For example, the communications device 830 may include atransceiver. The transceiver contains various electronic circuitrycomponents configured to conduct telecommunications with one or moreexternal devices. The electronic circuitry components allow thetransceiver to conduct telecommunications in one or more of the wired orwireless telecommunications protocols, including communicationsprotocols such as IEEE 802.11 (Wi-Fi), IEEE 802.15 (Bluetooth), GSM,CDMA, LTE, WIMAX, DLNA, HDMI, Medical Implant Communication Service(MICS), etc. In some embodiments, the transceiver includes antennas,filters, switches, various kinds of amplifiers such as low-noiseamplifiers or power amplifiers, digital-to-analog (DAC) converters,analog-to-digital (ADC) converters, mixers, multiplexers anddemultiplexers, oscillators, and/or phase-locked loops (PLLs). Some ofthese electronic circuitry components may be integrated into a singlediscrete device or an integrated circuit (IC) chip.

The electronic programmer 820A contains a touchscreen component 840. Thetouchscreen component 840 may display a touch-sensitive graphical userinterface that is responsive to gesture-based user interactions. Thetouch-sensitive graphical user interface may detect a touch or amovement of a user's finger(s) on the touchscreen and interpret theseuser actions accordingly to perform appropriate tasks. The graphicaluser interface may also utilize a virtual keyboard to receive userinput. In some embodiments, the touch-sensitive screen may be acapacitive touchscreen. In other embodiments, the touch-sensitive screenmay be a resistive touchscreen.

It is understood that the electronic programmer 820A may optionallyinclude additional user input/output components that work in conjunctionwith (or instead of) the touchscreen component 840 to carry outcommunications with a user. For example, these additional userinput/output components may include physical and/or virtual buttons(such as power and volume buttons) on or off the touch-sensitive screen,physical and/or virtual keyboards, mouse, track balls, speakers,microphones, light-sensors, light-emitting diodes (LEDs), communicationsports (such as USB or HDMI ports), joy-sticks, etc.

The electronic programmer 820A contains an imaging component 850. Theimaging component 850 is configured to capture an image of a targetdevice via a scan. For example, the imaging component 850 may be acamera in some embodiments. The camera may be integrated into theelectronic programmer 820A. The camera can be used to take a picture ofa medical device, or scan a visual code of the medical device, forexample its barcode or Quick Response (QR) code.

The electronic programmer contains a memory storage component 860. Thememory storage component 860 may include system memory, (e.g., RAM),static storage 608 (e.g., ROM), or a disk drive (e.g., magnetic oroptical), or any other suitable types of computer readable storagemedia. For example, some common types of computer readable media mayinclude floppy disk, flexible disk, hard disk, magnetic tape, any othermagnetic medium, CD-ROM, any other optical medium, RAM, PROM, EPROM,FLASH-EPROM, any other memory chip or cartridge, or any other mediumfrom which a computer is adapted to read. The computer readable mediummay include, but is not limited to, non-volatile media and volatilemedia. The computer readable medium is tangible, concrete, andnon-transitory. Logic (for example in the form of computer software codeor computer instructions) may be encoded in such computer readablemedium. In some embodiments, the memory storage component 860 (or aportion thereof) may be configured as a local database capable ofstoring electronic records of medical devices and/or their associatedpatients.

The electronic programmer contains a processor component 870. Theprocessor component 870 may include a central processing unit (CPU), agraphics processing unit (GPU) a micro-controller, a digital signalprocessor (DSP), or another suitable electronic processor capable ofhandling and executing instructions. In various embodiments, theprocessor component 870 may be implemented using various digital circuitblocks (including logic gates such as AND, OR, NAND, NOR, XOR gates,etc.) along with certain software code. In some embodiments, theprocessor component 870 may execute one or more sequences computerinstructions contained in the memory storage component 860 to performcertain tasks.

It is understood that hard-wired circuitry may be used in place of (orin combination with) software instructions to implement various aspectsof the present disclosure. Where applicable, various embodimentsprovided by the present disclosure may be implemented using hardware,software, or combinations of hardware and software. Also, whereapplicable, the various hardware components and/or software componentsset forth herein may be combined into composite components comprisingsoftware, hardware, and/or both without departing from the spirit of thepresent disclosure. Where applicable, the various hardware componentsand/or software components set forth herein may be separated intosub-components comprising software, hardware, or both without departingfrom the scope of the present disclosure. In addition, where applicable,it is contemplated that software components may be implemented ashardware components and vice-versa.

It is also understood that the electronic programmer 820A is notnecessarily limited to the components 830-870 discussed above, but itmay further include additional components that are used to carry out theprogramming tasks. These additional components are not discussed hereinfor reasons of simplicity. It is also understood that the medicalinfrastructure 800 may include a plurality of electronic programmerssimilar to the electronic programmer 820A discussed herein, but they arenot illustrated in FIG. 30 for reasons of simplicity.

The medical infrastructure 800 also includes an institutional computersystem 890. The institutional computer system 890 is coupled to theelectronic programmer 820A. In some embodiments, the institutionalcomputer system 890 is a computer system of a healthcare institution,for example a hospital. The institutional computer system 890 mayinclude one or more computer servers and/or client terminals that mayeach include the necessary computer hardware and software for conductingelectronic communications and performing programmed tasks. In variousembodiments, the institutional computer system 890 may includecommunications devices (e.g., transceivers), user input/output devices,memory storage devices, and computer processor devices that may sharesimilar properties with the various components 830-870 of the electronicprogrammer 820A discussed above. For example, the institutional computersystem 890 may include computer servers that are capable ofelectronically communicating with the electronic programmer 820A throughthe MICS protocol or another suitable networking protocol.

The medical infrastructure 800 includes a database 900. In variousembodiments, the database 900 is a remote database—that is, locatedremotely to the institutional computer system 890 and/or the electronicprogrammer 820A. The database 900 is electronically or communicatively(for example through the Internet) coupled to the institutional computersystem 890 and/or the electronic programmer. In some embodiments, thedatabase 900, the institutional computer system 890, and the electronicprogrammer 820A are parts of a cloud-based architecture. In that regard,the database 900 may include cloud-based resources such as mass storagecomputer servers with adequate memory resources to handle requests froma variety of clients. The institutional computer system 890 and theelectronic programmer 820A (or their respective users) may both beconsidered clients of the database 900. In certain embodiments, thefunctionality between the cloud-based resources and its clients may bedivided up in any appropriate manner. For example, the electronicprogrammer 820A may perform basic input/output interactions with a user,but a majority of the processing and caching may be performed by thecloud-based resources in the database 900. However, other divisions ofresponsibility are also possible in various embodiments.

According to the various aspects of the present disclosure, thepain/stimulation maps may be uploaded from the electronic programmer820A to the database 900. The pain/stimulation maps saved in thedatabase 900 may thereafter be downloaded by any of the other electronicprogrammers 820B-820N communicatively coupled to it, assuming the userof these programmers has the right login permissions. For example, a 2Dpain/stimulation map may be generated by the electronic programmer 820Aand uploaded to the database 900, as discussed in detail in U.S. patentapplication Ser. No. 13/973,219, filed on Aug. 22, 2013, entitled“Method and System of Producing 2D Representations of 3D Pain andStimulation Maps and Implant Models on a Clinician Programmer,” toNorbert Kaula, et al., the disclosure of which is hereby incorporated byreference in its entirety. That 2D pain/stimulation map can then bedownloaded by the electronic programmer 820B, which can use thedownloaded 2D pain/stimulation map to reconstruct or recreate a 3Dpain/stimulation map. In this manner, a less data-intensive 2Dpain/stimulation map may be derived from a data-heavy 3Dpain/stimulation map, sent to a different programmer through thedatabase, and then be used to reconstruct the 3D pain/stimulation map.It is understood that the pain/stimulation map migration historydiscussed above with reference to FIGS. 14-15 or the concurrentlydisplayed maps discussed above with reference to FIGS. 16-25 may also besent to the database 900 for storage.

The database 900 may also include a manufacturer's database in someembodiments. It may be configured to manage an electronic medical deviceinventory, monitor manufacturing of medical devices, control shipping ofmedical devices, and communicate with existing or potential buyers (suchas a healthcare institution). For example, communication with the buyermay include buying and usage history of medical devices and creation ofpurchase orders. A message can be automatically generated when a client(for example a hospital) is projected to run out of equipment, based onthe medical device usage trend analysis done by the database. Accordingto various aspects of the present disclosure, the database 900 is ableto provide these functionalities at least in part via communication withthe electronic programmer 820A and in response to the data sent by theelectronic programmer 820A. These functionalities of the database 900and its communications with the electronic programmer 820A will bediscussed in greater detail later.

The medical infrastructure 800 further includes a manufacturer computersystem 910. The manufacturer computer system 910 is also electronicallyor communicatively (for example through the Internet) coupled to thedatabase 900. Hence, the manufacturer computer system 910 may also beconsidered a part of the cloud architecture. The computer system 910 isa computer system of medical device manufacturer, for example amanufacturer of the medical devices 810 and/or the electronic programmer820A.

In various embodiments, the manufacturer computer system 910 may includeone or more computer servers and/or client terminals that each includesthe necessary computer hardware and software for conducting electroniccommunications and performing programmed tasks. In various embodiments,the manufacturer computer system 910 may include communications devices(e.g., transceivers), user input/output devices, memory storage devices,and computer processor devices that may share similar properties withthe various components 830-870 of the electronic programmer 820Adiscussed above. Since both the manufacturer computer system 910 and theelectronic programmer 820A are coupled to the database 900, themanufacturer computer system 910 and the electronic programmer 820A canconduct electronic communication with each other.

The system 800 allows for comparative analysis to be conducted based onthe pain/stimulation map migration history discussed above withreference to FIGS. 14-15. For example, the migration history of thepain/stimulation maps may be gathered from a plurality of patients viathe electronic programmers 820A-820N. The privacy information of thesepatients is stripped or removed. For example, the patient's name,address, phone number, or employ may be removed to comply with HealthInsurance Portability and Accountability Act (HIPPA) rules. Otherrelevant non-sensitive patient information (e.g., patient'sphysiological profile such as gender, height, or weight, or even medicalhistory) may be retained if permitted by HIPPA. In this manner, aplurality of anonymous pain/stimulation map migration histories may bestored, for example in the database 900, along with certain types ofpatient information as discussed above.

A healthcare professional may thereafter download these conglomeratedpain/stimulation migration histories and/or send them to a remote serverfor analysis. The remote server may include the database 900, theinstitutional computer system 890, the manufacturer computer system 910,or another suitable remote server not illustrated herein. In somesituations, the analysis may detect certain pain/stimulation migrationtrends, which may be associated with their respective patient'sphysiological characteristics or medical histories. Based on this trendinformation, the healthcare professional may be able to better diagnoseor treat his/her patient.

As an example, supposed the current patient is a 40-year old white malewho is 6 feet tall and weighs 200 pounds, and who has had a kneereplacement performed in the past few years due to a sports-relatedinjury. The healthcare professional treating this patient may scour thedatabase 900 to see if there are any close matches for this particularpatient's profile. If one or more close matches are identified, theirassociated pain map migration histories may be retrieved. The healthcareprofessional may study these pain map migration histories, which are forpatients similar to the current patient. Based on this information, thehealthcare professional may be able to estimate with more accuracy howthis particular patient's pain is likely to evolve or migrate over time.Accordingly, the healthcare professional may be able to formulate atreatment plan that is not only targeted toward this patient's currentpain symptoms, but also directed to how this patient's pain is likely toevolve in the future. In this manner, the pain/stimulation map migrationhistories may be used to aid the healthcare professional in diagnosingand treating his/her current patient.

FIG. 31A is a side view of a spine 1000, and FIG. 31B is a posteriorview of the spine 1000. The spine 1000 includes a cervical region 1010,a thoracic region 1020, a lumbar region 1030, and a sacrococcygealregion 1040. The cervical region 1010 includes the top 7 vertebrae,which may be designated with C1-C7. The thoracic region 1020 includesthe next 12 vertebrae below the cervical region 1010, which may bedesignated with T1-T12. The lumbar region 1030 includes the final 5“true” vertebrae, which may be designated with L1-L5. The sacrococcygealregion 1040 includes 9 fused vertebrae that make up the sacrum and thecoccyx. The fused vertebrae of the sacrum may be designated with S1-S5.

Neural tissue (not illustrated for the sake of simplicity) branch offfrom the spinal cord through spaces between the vertebrae. The neuraltissue can be individually and selectively stimulated in accordance withvarious aspects of the present disclosure. For example, referring toFIG. 31B, an IPG device 1100 is implanted inside the body. The IPGdevice 1100 may include a neurostimulator device. A conductive lead 1110is electrically coupled to the circuitry inside the IPG device 1100. Theconductive lead 1110 may be removably coupled to the IPG device 1100through a connector, for example. A distal end of the conductive lead1110 is attached to one or more electrodes 1120. The electrodes 1120 areimplanted adjacent to a desired nerve tissue in the thoracic region1020. Using well-established and known techniques in the art, the distalend of the lead 1110 with its accompanying electrodes may be positionedalong or near the epidural space of the spinal cord. It is understoodthat although only one conductive lead 1110 is shown herein for the sakeof simplicity, more than one conductive lead 1110 and correspondingelectrodes 1120 may be implanted and connected to the IPG device 1100.

The electrodes 1120 deliver current drawn from the current sources inthe IPG device 1100, therefore generating an electric field near theneural tissue. The electric field stimulates the neural tissue toaccomplish its intended functions. For example, the neural stimulationmay alleviate pain in an embodiment. In other embodiments, a stimulatormay be placed in different locations throughout the body and may beprogrammed to address a variety of problems, including for example butwithout limitation; prevention or reduction of epileptic seizures,weight control or regulation of heart beats.

It is understood that the IPG device 1100, the lead 1110, and theelectrodes 1120 may be implanted completely inside the body, may bepositioned completely outside the body or may have only one or morecomponents implanted within the body while other components remainoutside the body. When they are implanted inside the body, the implantlocation may be adjusted (e.g., anywhere along the spine 1000) todeliver the intended therapeutic effects of spinal cord electricalstimulation in a desired region of the spine. Furthermore, it isunderstood that the IPG device 1100 may be controlled by a patientprogrammer or a clinician programmer 1200, the implementation of whichmay be similar to the clinician programmer shown in FIG. 28.

The foregoing has outlined features of several embodiments so that thoseskilled in the art may better understand the detailed description thatfollows. Those skilled in the art should appreciate that they mayreadily use the present disclosure as a basis for designing or modifyingother processes and structures for carrying out the same purposes and/orachieving the same advantages of the embodiments introduced herein.Those skilled in the art should also realize that such equivalentconstructions do not depart from the spirit and scope of the presentdisclosure, and that they may make various changes, substitutions andalterations herein without departing from the spirit and scope of thepresent disclosure.

What is claimed is:
 1. An electronic device for displaying pain orstimulation experienced by a patient, the electronic device comprising:a graphical user interface configured to receive an input from a userand display a visual output to the user; a memory storage componentconfigured to store programming code; and a computer processorconfigured to execute the programming code to perform the followingtasks: concurrently displaying a first map and a second map via thegraphical user interface, wherein the first map and the second map areeach a pain map or a stimulation map, wherein the pain map represents abody area of the patient experiencing pain, and wherein the stimulationmap represents a body area of the patient experiencing electricalstimulation; displaying a virtual control mechanism via the graphicaluser interface; detecting, through the graphical user interface, anengagement of the virtual control mechanism; and adjusting, in responseto the engagement of the virtual control mechanism, a respective visualemphasis of the first map and the second map, further comprising:increasing a visual emphasis of at least a portion of the first mapwhile decreasing a visual emphasis of at least a portion of the secondmap; or decreasing the visual emphasis of at least a portion of thefirst map while increasing the visual emphasis of at least a portion ofthe second map.
 2. The electronic device of claim 1, wherein: the firstmap is a pain map; and the second map is a stimulation map.
 3. Theelectronic device of claim 1, wherein the first map and the second mapare the same type of maps that are one of: acquired from differentpoints in time; acquired in response to different stimulation programs;or acquired from different patients.
 4. The electronic device of claim1, wherein the concurrently displaying of the first map and the secondmap comprises displaying an overlap region between the first map and thesecond map.
 5. The electronic device of claim 4, wherein the tasksfurther comprise displaying a numerical value that indicates a size ofthe overlap region relative to a size of one of: the first map and thesecond map.
 6. The electronic device of claim 1, wherein the first mapis a pain map and the second map is a stimulation map, and wherein thetasks further comprise displaying a sign if a portion of the stimulationmap lies outside of the pain map.
 7. The electronic device of claim 1,wherein: the displaying of the virtual control mechanism comprisesdisplaying an elongate slider bar and a marker configured to be movedalong the slide bar; the detecting of the one or more engagements of thevirtual control mechanism comprises detecting a movement of the markeralong the slider bar in one of a first direction and a second directiondifferent from the first direction; the increasing of the visualemphasis of at least a portion of the first map and the decreasing ofthe visual emphasis of at least a portion of the second map areperformed in response to a detected movement of the marker along theslider bar in the first direction; and the decreasing of the visualemphasis of at least a portion of the first map and the increasing ofthe visual emphasis of at least a portion of the second map areperformed in response to a detected movement of the marker along theslider bar in the second direction.
 8. The electronic device of claim 1,wherein the tasks further comprise: adjusting a visual emphasis of apredefined region of one of the first and second maps.
 9. A medicalsystem, comprising: one or more medical devices configurable to delivera medical therapy to a patient; and an electronic device configured toprogram the one or more medical devices, wherein the electronic deviceincludes: a graphical user interface configured to receive an input froma user and display a visual output to the user; a memory storagecomponent configured to store computer instructions; and a processorcomponent configured to execute the computer instructions to perform thefollowing tasks: concurrently displaying a first map and a second mapvia the graphical user interface, wherein the first map and the secondmap are each a pain map or a stimulation map, wherein the pain maprepresents a body area of the patient experiencing pain, and wherein thestimulation map represents a body area of the patient experiencingelectrical stimulation; displaying a virtual control mechanism via thegraphical user interface; detecting, through the graphical userinterface, an engagement of the virtual control mechanism; andadjusting, in response to the engagement of the virtual controlmechanism, a respective visual emphasis of the first map and the secondmap, further comprising: increasing a visual emphasis of at least aportion of the first map while decreasing a visual emphasis of at leasta portion of the second map; or decreasing the visual emphasis of atleast a portion of the first map while increasing the visual emphasis ofat least a portion of the second map.
 10. The medical system of claim 9,wherein: the first map is a pain map; and the second map is astimulation map.
 11. The medical system of claim 9, wherein the firstmap and the second map are the same type of maps that are one of:acquired from different points in time; acquired in response todifferent stimulation programs; or acquired from different patients. 12.The medical system of claim 9, wherein the concurrently displaying ofthe first map and the second map comprises displaying an overlap regionbetween the first map and the second map.
 13. The medical system ofclaim 12, wherein the tasks further comprise displaying a numericalvalue that indicates a size of the overlap region relative to a size ofone of: the first map and the second map.
 14. The medical system ofclaim 9, wherein the first map is a pain map and the second map is astimulation map, and wherein the tasks further comprise displaying asign if a portion of the stimulation map lies outside of the pain map.15. The medical system of claim 9, wherein: the displaying of thevirtual control mechanism comprises displaying an elongate slider barand a marker configured to be moved along the slide bar; the detectingof the one or more engagements of the virtual control mechanismcomprises detecting a movement of the marker along the slider bar in oneof a first direction and a second direction different from the firstdirection; the increasing of the visual emphasis of at least a portionof the first map and the decreasing of the visual emphasis of at least aportion of the second map are performed in response to a detectedmovement of the marker along the slider bar in the first direction; andthe decreasing of the visual emphasis of at least a portion of the firstmap and the increasing of the visual emphasis of at least a portion ofthe second map are performed in response to a detected movement of themarker along the slider bar in the second direction.
 16. The medicalsystem of claim 9, wherein the tasks further comprise: adjusting avisual emphasis of a predefined region of one of the first and secondmaps.
 17. A method of displaying pain or stimulation experienced by apatient, the method comprising: providing a graphical user interfaceconfigured to receive an input from a user and display a visual outputto the user; concurrently displaying a first map and a second map viathe graphical user interface, wherein the first map and the second mapare each a pain map or a stimulation map, wherein the pain maprepresents a body area of the patient experiencing pain, and wherein thestimulation map represents a body area of the patient experiencingelectrical stimulation; displaying a virtual control mechanism via thegraphical user interface; detecting, through the graphical userinterface, an engagement of the virtual control mechanism; andadjusting, in response to the engagement of the virtual controlmechanism, a respective visual emphasis of the first map and the secondmap, further comprising: increasing a visual emphasis of at least aportion of the first map while decreasing a visual emphasis of at leasta portion of the second map; or decreasing the visual emphasis of atleast a portion of the first map while increasing the visual emphasis ofat least a portion of the second map; wherein the providing of thegraphical user interface, the concurrently displaying the pain map andthe stimulation map, the displaying of the virtual control mechanism,the detecting of the engagement of the virtual control mechanism, andthe adjusting of the respective visual emphasis are each performed byone or more electronic processors.
 18. The method of claim 17, wherein:the first map is a pain map; and the second map is a stimulation map.19. The method of claim 17, wherein the first map and the second map arethe same type of maps that are one of: acquired from different points intime; acquired in response to different stimulation programs; oracquired from different patients.
 20. The method of claim 17, whereinthe concurrently displaying of the first map and the second mapcomprises displaying an overlap region between the first map and thesecond map.
 21. The method of claim 20, further comprising displaying anumerical value that indicates a size of the overlap region relative toa size of one of: the first map and the second map.
 22. The method ofclaim 17, wherein the first map is a pain map and the second map is astimulation map, and further comprising displaying a sign if a portionof the stimulation map lies outside of the pain map.
 23. The method ofclaim 17, wherein: the displaying of the virtual control mechanismcomprises displaying an elongate slider bar and a marker configured tobe moved along the slide bar; the detecting of the one or moreengagements of the virtual control mechanism comprises detecting amovement of the marker along the slider bar in one of a first directionand a second direction different from the first direction; theincreasing of the visual emphasis of at least a portion of the first mapand the decreasing of the visual emphasis of at least a portion of thesecond map are performed in response to a detected movement of themarker along the slider bar in the first direction; and the decreasingof the visual emphasis of at least a portion of the first map and theincreasing of the visual emphasis of at least a portion of the secondmap are performed in response to a detected movement of the marker alongthe slider bar in the second direction.
 24. The method of claim 17,further comprising: adjusting a visual emphasis of a predefined regionof one of the first and second maps.